Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center

NCT06897982 | Recruiting

• 2 other identifiers: STUDY000040617K23DK129828-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the feasibility and acceptability of incorporating hands-on nutritional demonstrations to enhance the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes

Conditions

Obesity Prevention; Prediabetic State; PreDiabetes; Health Knowledge, Attitudes, Practice; Nutrition, Healthy; Acceptability of Health Care

Outcome Measures

Primary Outcomes (1)

• Retention

  The primary outcome of this feasibility study will be retention in the DPP. Retention will be defined as participation in 9 of the 16 core DPP sessions during months 1 through 6 of the DPP. This measure will assess participant completion of the DPP. % retention will be measured at the end of the DPP.

  Post-Intervention (12-months as DPP is a year-long program)

Secondary Outcomes (2)

• Recruitment Rate of Participants for Nutrition Intervention

  Baseline and During Intervention (Weeks 1-7)

• Change in Participant Acceptability of the Nutrition Intervention

  During & Post-Intervention (Weeks 1-7)

Other Outcomes (8)

• Healthy Food Environment Assessment

  Pre-Intervention at Baseline in Week 1

• Change in Food Insecurity

  Pre- and Post-intervention (Baseline in Week 1, and Week 7)

• Change in Self-Efficacy

  Pre, During and Post-Intervention (Baseline in Week 1, Week 4, Final session in 7th week)

Study Arms (1)

DPP Clinic Participants

EXPERIMENTAL

A single arm approach with two groups of ten collected a two different time points in the year of the clinic's DPP. These will not be compared to each other they will be used to collect feasibility outcomes data to inform a future pilot randomized study

Behavioral: One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles

Interventions

One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles BEHAVIORAL

This clinical trial incorporates a behavioral intervention as the primary outcome of Aim 3 is to assess the feasibility and acceptability of adding an educational intervention using nutritional demonstrations aligned with the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes. The purpose of this study is to assess if having a nutritional demonstration as part of the DPP would be accepted by clinic DPP patients and hear their perspectives about if this would help them in achieving DPP goals of achieving at least 5% weight loss and implementing sustainable lifestyle changes with healthy eating to reduce their risk of prediabetes. The intervention is designed to encourage healthier eating habits and encourage clinic DPP patients to incorporate this into their daily lives. This study will also determine if it is feasible to incorporate nutritional demonstrations to enhance the existing DPP curriculum

DPP Clinic Participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• BMI of 25 or higher (23 or higher if Asian)
• Meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4%
• Not be diagnosed with type 1 or type 2 diabetes
• Moderate to high risk of having prediabetes or a known diagnosis of prediabetes by their medical provider in the last 12 months.
• Eligible or enrolled in the Diabetes Prevention Program

You may not qualify if:

• Younger than 18 years of age
• BMI of less than 25 or higher (or under 23 if Asian)
• Does not meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4%
• Currently diagnosed with type 1 or type 2 diabetes
• Has not been diagnosed as moderate to high risk of having prediabetes or having a known diagnosis of prediabetes by their medical provider in the last 12 months.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Yelba Castellon-Lopez, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Aguilar-Hernandez, BA

CONTACT

4243151042; leslie.aguilar-hernandez@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 27, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)